Current Clinical Trial Regulatory Environment & Key Strategies to Avoid an FDA Warning Letters
Sandra Maddock, RN, BSN, CCRA; IMARC Research Inc.
Stanley McDermott, PharmD, MS
Steve Schmidt, PhD
A random review of 25 warning letters issued by the FDA to clinical investigative sites in 2009 revealed that study teams are failing to meet the mark in several key areas including protocol compliance, maintenance of records and informed consent, among others.
This seminar will:
- Discuss the current regulatory environment and the implications for clinical investigators
- Identify regulations governing FDA regulated clinical research
- Implement pro-active strategies to help avoid receiving FDA warning letters
- Apply the regulations to three real-world scenarios utilizing the “FAIR Shake” technique
For more information on this seminar, download this month’s Synergy Seminar flyer (PDF) or email Synergy@abiakron.org.